Study shows Amgen’s new biosimilar cancer drug safe, effective

Pharmaceuticals Amgen and Allergan announced positive Phase 3 study results of their new drug ABP 215 on Sept. 23.

The drug, used to treat lung cancer, is being developed as a biosimilar to Roche Holding AG’s Avastin. ABP 215 showed clinical safety and effectiveness compared to Avastin.

“Lung cancer is the leading cause of cancer death in both men and women in the U.S. and the European Union,” said Sean Harper, executive vice president of research and development at Thousand Oaks-based Amgen in a news release. “ABP 215 holds the potential to advance access to treatment options for oncology patients.”

The study included 642 patients with non-small cell lung cancer. During the study, patients were given doses of the experimental drug once every three weeks, up to six times. Of those studied, 328 were given ABP 215 and 314 were given Avastin. Patients were then followed to see how their disease progressed.

Allergan was formerly based in Goleta and bought Westlake Village-based Kythera Biopharmaceuticals. Amgen and Allergan are working together to create four oncology biosimilar drugs. Amgen is also developing nine biosimilars while Allergan develops its own biosimilars.

Ironically, biosimilars are threatening Amgen right now. Biosimilars are like generics but they aren’t identical to the complex compounds they replicate and are made with living organisms. They threaten the multi-billion dollar sales of drugs made by Amgen, Allergan and other companies because they cost less than brand name biotech drugs.

Amgen has sued companies that have made drugs similar to Amgen’s. In March, Amgen sued rival Novartis for making a biosimilar that mimics Amgen’s drug that helps chemotherapy patients battle infections by increasing the production of white blood cells.

The U.S. Food and Drug Administration approved Zarxio in March but Amgen sued, stalling its debut. An appeals court ruled in July that Novartis could begin selling the drug on Sept. 2. Amgen’s temporary injunction was removed Sept. 3.

Amgen said in a news release on Sept. 23 that while developing biosimilars the company can build upon its long history of developing innovative drugs.

“Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide,” Amgen officials said.